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Open Label Study Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque Type Psoriasis

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ClinicalTrials.gov Identifier: NCT00800982
Recruitment Status : Completed
First Posted : December 3, 2008
Results First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 13, 2008
First Posted Date  ICMJE December 3, 2008
Results First Submitted Date  ICMJE February 19, 2013
Results First Posted Date  ICMJE May 7, 2013
Last Update Posted Date May 7, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below. [ Time Frame: Weeks 12-24 ]
Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
To evaluate, after 12 weeks on the etanercept induction dose (50 mg twice a week), the effectiveness of NB-UVB phototherapy in enhancing the efficacy of etanercept's maintenance dose (50 mg once a week) in the treatment of obese patients. [ Time Frame: Weeks 12-24 ]
Change History Complete list of historical versions of study NCT00800982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Prevention of "step down" deterioration following the initiation of the maintenance dose [ Time Frame: Weeks 12-24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque Type Psoriasis
Official Title  ICMJE A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Tolerability of Narrow Band UVB Phototherapy in Enhancing Etanercept's Maintenance Dose in Obese Patients With Moderate to Severe Plaque-Type Psoriasis
Brief Summary This is a single-center, open-label, pilot study. A total of 30 subjects (15 in each study arm) will be enrolled in this 6 month study to evaluate whether the addition of narrow band UVB (NB-UVB) phototherapy can enhance the efficacy of etanercept's maintenance dose, 50 mg once a week, in obese psoriasis patients.
Detailed Description In Phase I, all subjects will receive etanercept's induction dose, 50 mg twice a week, for a total of 12 weeks. In Phase II, all subjects will receive etanercept's maintenance dose, 50 mg once a week, during Weeks 12-24. Those subjects randomized to the treatment arm will receive NB-UVB phototherapy 3 times a week during Phase II. In order to ensure homogeneity between the NB-UVB arm and non-NB-UVB arm, subjects will be randomized according to their Body Mass Index (BMI). The Psoriasis Area Severity Index (PASI) score and Physician Global Assessment (PGA) will be calculated at each visit to determine the effectiveness of the etanercept and NB-UVB treatment during both phases of the study. The hypothesis is that the combination of NB-UVB phototherapy three times a week and etanercept maintenance dose (50 mg once a week) will enhance the efficacy of the maintenance dose alone in obese patients (BMI >30) with moderate to severe psoriasis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy
    Narrow band (310-312 nm) ultraviolet light B phototherapy 3 times a week during Weeks 12-24. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff
    Other Names:
    • nb-UVB
    • nbUVB
    • narrowband UVB
  • Drug: etanercept
    Etanercept is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.
    Other Name: Enbrel
Study Arms  ICMJE
  • Active Comparator: 1 (Etanercept only)
    Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
    Intervention: Drug: etanercept
  • Experimental: 2 (Etanercept + nb-UVB)

    Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.

    In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff.

    Interventions:
    • Procedure: Narrow band (310-312 nm) ultraviolet light B phototherapy
    • Drug: etanercept
Publications * Park KK, Wu JJ, Koo J. A randomized, 'head-to-head' pilot study comparing the effects of etanercept monotherapy vs. etanercept and narrowband ultraviolet B (NB-UVB) phototherapy in obese psoriasis patients. J Eur Acad Dermatol Venereol. 2013 Jul;27(7):899-906. doi: 10.1111/j.1468-3083.2012.04611.x. Epub 2012 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nonimmunocompromised males or females 18 years of age or older.
  • Must be able to read, understand, and speak basic English.
  • Body Surface Area (BSA) involvement of greater than 10%.
  • Psoriasis Area and Severity Index greater than 10.
  • Obese defined as having a Body Mass Index greater than 30.
  • Eligible for systemic therapy, particularly etanercept, and Narrow Band Ultraviolet B in the opinion of the investigator.
  • Sign and date the appropriate written informed consent and Health Insurance Portability and Accountability Act authorization
  • Negative urine pregnancy test within 7 days before the first dose of etanercept in all women (except those surgically sterile or at least 5 years postmenopausal).
  • No evidence of active or latent tuberculosis based on a negative Purified Protein Derivative skin test. Patients with documentation of adequately treated tuberculosis may be enrolled.
  • Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study.
  • Willing and able to self-administer subcutaneous injections or to have a qualified person available to administer subcutaneous injections
  • Agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject
  • Meets concomitant medication washout requirements

Exclusion Criteria:

  • Erythrodermic, pustular, or guttate psoriasis
  • Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
  • Known sensitivity to any component of the study medications.
  • Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits.
  • Evidence of latent or active hepatitis B infection as indicated by positive HBsAg test during the screening visit.
  • Personal or first degree family history of neurologic disease.
  • Poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk.
  • History of any Tumor Necrosis Factor-α inhibitor use including etanercept, infliximab, and adalimumab within 4 weeks of starting study drug.
  • History of non-cutaneous malignancy within the past 5 years.
  • History of drug or alcohol abuse. Substance abuse must clearly be documented so those patients with a remote and minor history of drug/alcohol use will still have an opportunity to participate in the study.
  • Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  • Plans to receive any live vaccines during the study.
  • Evidence of photosensitivity disorder (i.e. polymorphous light eruption).
  • Known photosensitivity or known sensitivity to any of the excipients or products to be administered during dosing.
  • Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to Week 0
  • Cannot commit to all the assessments required by the protocol
  • Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
  • Considered by the investigator, for any reason, to be an unsuitable candidate for study participation.
  • Cannot or do not wish to comply with the protocol washout requirements (please see section below entitled "Washout Period Prior to Week 0).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800982
Other Study ID Numbers  ICMJE KOO - ENBREL-2008
H5939-31693-01 ( Other Identifier: UCSF Committee for Human Research )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Koo, MD UCSF Psoriasis and Skin Treatment Center, Department of Dermatology, University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP